Method and compositions for treating hematological malignancies

Abstract

A compound of formula 1 and/or its salts, tautomers or solvates is used to treat hematological malignancies. In an embodiment, an organic acid salt of compound 1 is provided for general use in treatment of neoplasms, and in a further embodiment the salt is stabilized with carbohydrate.

1 . An organic acid salt of the compound  
     
       
         
         
             
             
         
       
     
     and/or its tautomers and solvates.  
   
   
       2 . The salt of  claim 1  wherein the organic acid is succinic acid.  
   
   
       3 . A sterile aqueous solution comprising the salt of  claim 1  and a carbohydrate.  
   
   
       4 . A method comprising administering to a patient having a neoplasm a therapeutically effective dose of the salt of  claim 1 .  
   
   
       5 . A combination comprising (a) a container suitable for a parenteral pharmaceutical product and disposed therein (b) a therapeutically effective dose of the compound  
     
       
         
         
             
             
         
       
     
     and/or its salts, tautomers and solvates.  
   
   
       6 . The combination of  claim 5  wherein the compound is in a substantially isotonic aqueous solution.  
   
   
       7 . The combination of  claim 5  wherein the compound is a salt with at least one organic acid.  
   
   
       8 . The combination of  claim 7  wherein the organic acid is succinic acid.  
   
   
       9 . The combination of  claim 5  wherein the container comprises a sterile port.  
   
   
       10 . The combination of  claim 5  wherein the container is a vial or flexible bag.  
   
   
       11 . A method for the treatment of a patient having a hematological malignancy comprising administering to the patient a therapeutically effective amount of the compound  
     
       
         
         
             
             
         
       
     
     and/or its salts, tautomers and solvates.  
   
   
       12 . The method of  claim 11  wherein the hematological malignancy is multiple myeloma or myelodysplastic syndrome.  
   
   
       13 . The method of  claim 11  wherein the hematological malignancy is a leukemia or lymphoma.  
   
   
       14 . The method of  claim 11  wherein an organic acid salt of the compound is administered.  
   
   
       15 . The method of  claim 11  wherein the compound is administered parenterally.  
   
   
       16 . A composition comprising the compound  
     
       
         
         
             
             
         
       
     
     and/or its salts, tautomers and solvates, and at least one other agent useful for the treatment of a hematological malignancy.  
   
   
       17 . A method comprising preparing an organic acid salt of the compound  
     
       
         
         
             
             
         
       
     
     and a carbohydrate in a sterile aqueous solution, and storing said solution for a period exceeding about 1 hour.  
   
   
       18 . A packaged composition comprising a sterile aqueous solution of (a) a carbohydrate and (b) an organic acid salt of the compound  
     
       
         
         
             
             
         
       
     
     and/or its tautomers and solvates, together with disclosure that the solution optionally is stored for a period greater than about 1 hour.  
   
   
       19 . A kit comprising (a) a container suitable for a parenteral pharmaceutical product, (b) a therapeutically effective dose of the compound  
     
       
         
         
             
             
         
       
     
     and/or its salts, tautomers and solvates; and 
 (c) instructions for the use of the compound and the container.  
 
   
   
       20 . The use of a compound having the structure  
     
       
         
         
             
             
         
       
     
     and/or its salts, tautomers and solvates, in the manufacture of a medicament for the treatment of a hematological malignancy.  
   
   
       21 . A compound or method as disclosed herein.